When designing medical device products, sterilization should be considered as early in the development as possible to ensure the material challenges of the sterilization process on the product and packaging. AAMI TIR 17:2008 titled "Compatibility of materials subject to sterilization" is a very important reference.
EO is highly compatible with polymer-based, single-use medical devices, procedure kits and surgical trays. PVA, PGA, and PLA is not compatible with EO sterilization.
The Gamma irradiation process can modify polymers, add an ozone odor to the package contents, or cause some discoloring and embrittlement. Gamma irradiation also has undesirable consequences due to the potential production of toxic degradation products such as 4,4’-methylenedianiline (MDA) that can be produced when a high-molecular-weight polyurethane material decomposes as a consequence of irradiation. Polypropylene, PTFE, and polyacetals is not compatible with radiation sterilization.
A good summary of materials which can be used in Gamma ray irradiation is from Steris Company and Nordion.
EO is highly compatible with polymer-based, single-use medical devices, procedure kits and surgical trays. PVA, PGA, and PLA is not compatible with EO sterilization.
The Gamma irradiation process can modify polymers, add an ozone odor to the package contents, or cause some discoloring and embrittlement. Gamma irradiation also has undesirable consequences due to the potential production of toxic degradation products such as 4,4’-methylenedianiline (MDA) that can be produced when a high-molecular-weight polyurethane material decomposes as a consequence of irradiation. Polypropylene, PTFE, and polyacetals is not compatible with radiation sterilization.
A good summary of materials which can be used in Gamma ray irradiation is from Steris Company and Nordion.
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